Graves' Disease
Conditions
Keywords
Graves', Graves' Disease, Hyperthyroidism, Autoimmune thyroid disease, TSH receptor antibodies
Brief summary
This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.
Interventions
DRUGExperimental: YB-101
YB-101 is administered over a 24 week period.
DRUGPlacebo YB-101
Placebo will be administered over a 24 week period.
Sponsors
Yarrow Bioscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a documented diagnosis of Graves' Disease confirmed by the presence of thyroid-stimulating hormone receptor antibodies (TRAbs) by medical history or screening laboratory assessment * Have a pre-existing diagnosis of TED or, conversely, no evidence of TED at the ophthalmological examination performed during screening * Additional inclusion criteria are defined in the protocol
Exclusion criteria
* Previously treated with radioactive iodine (RAI) therapy or underwent total thyroidectomy * Received any dose of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening * Current treatment with teprotumumab or exposure to teprotumumab within 15 weeks prior to screening * History of hyperthyroidism not caused by Graves' disease (eg. toxic adenoma, or toxic multinodular goiter) within 6 months before the screening visit * Pregnant or lactating women * Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) | Baseline, Day 169 |
| Proportion of participants with normal free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) who discontinued anti-thyroid drugs (ATDs), regardless of concomitant levothyroxine use | Baseline, Day 169 |
Countries
Australia, United States
Contacts
CONTACTVictoria Lacasse, MD
Outcome results
None listed